Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.1 µg/L
Assessment factor:
2
Extrapolation method:
sensitivity distribution

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.5 µg/L
Assessment factor:
2
Extrapolation method:
sensitivity distribution

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
174 mg/kg sediment dw
Assessment factor:
3
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
164 mg/kg sediment dw
Assessment factor:
3
Extrapolation method:
sensitivity distribution

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
212 mg/kg soil dw
Assessment factor:
1
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10.9 mg/kg food
Assessment factor:
6

Additional information

In assessing the ecotoxicity of metals in the various environmental compartments (aquatic, terrestrial and sediment), it is assumed that toxicity is not controlled by the total concentration of a metal, but by the bioavailable form. For metals, this bioavailable form is generally accepted to be the free metal-ion in solution. In the absence of speciation data and as a conservative approximation, it can also be assumed that the total soluble lead pool is bioavailable. Ale reliable data on ecotoxicity and environmental fate and behaviour of lead and lead substances were therefore selected based on soluble Pb salts or measured (dissolved) Pb concentration.

The reliable ecotoxicity data selected for effects assessment of Pb in the various environmental compartments are derived from tests with soluble Pb salts (lead (di)nitrate, lead carbonate, lead acetate, lead chloride). Since lead is the toxic component and the anions do not contribute to toxicity, all reliable data are grouped together in a read-across approach and the PNEC’s are expressed as µg Pb/L (measured dissolved concentration) of mg/kg Pb. These results can be used for all other Pb compounds without concenter on toxicity of the anions.

Attached a document on the PNEC derivation for the aquatic and terrestrial environment describes the process in detail.

Conclusion on classification

For ERV derivation the general rules according to the ‘Guidance on the application of the CLP criteria (ECHA, 2012)’ have been followed. Therefore, for determining acute/chronic aquatic toxicity for classification purposes data should be generated according to standardised test methods (or from validated and internationally accepted test methods). For acute ERV derivation LC50 values were used, while for chronic ERV derivation NOECs or the equivalent L(E)C10 were used. Unbounded toxicity values were not further considered for ERV derivation.

Furthermore, where 4 or more ecotoxicity data on the same species and endpoint were available, the data were grouped, and the geometric mean used as a representative toxicity value for that species. In other cases (> 4 data points), the lowest representative toxicity value was selected.

For the classification of metals, Transformation/Dissolution is carried out over a pH range. Ideally both T/D and ecotoxicity data are compared at a similar pH since both parameters will vary with pH. Because T/Dp tests are typically performed between pH 5,5 - 8,5, we have 'separated' the toxicity data according to 3 different pH ranges, ie 5,5-6,5/6,5-7,5/7,5-8,5.

- Acute reference values

An overview of the selected high quality species mean/lowest acute toxicity data for the 3 different pH classes is provided in the Table below.

Table xxx: Overview of the selected high quality short-term toxicity data for the individual species (L(E)C50values expressed as µg/L) for the 3 pH classes (lowest values in bold)

Test organism

Standard method

L(E)C50 (µg/L)

pH: 5.5-6.5

pH: >6.5-7.5

pH: >7.5-8.5

Algae

 

 

 

 

Pseudokirchnerella subcapitata

n

Min.

Max.

Geometric mean/lowest value

OECD 201

 

6

72.0

364.0

163.7

 

6

26.6

79.5

37.8

 

3

20.5

49.6

20.5

Chlorella kessleri

n

Min.

Max.

Geometric mean/lowest value

OECD 201[1]

 

1

388.0

388.0

388.0

 

/

/

/

/

 

/

/

/

/

Invertebrates

 

 

 

 

Daphnia magna

n

Min.

Max.

Geometric mean/lowest value

OECD 202

 

/

/

/

/

 

/

/

/

/

 

3

337.1

364.5

337.1

Ceriodaphnia dubia

n

Min.

Max.

Geometric mean/lowest value

EPA-821-R-02-012

 

3

73.6

655.6

73.6

 

16

28.8

1,179.6

240.6

 

20

26.4

3,115.8

300.6

Fish

 

 

 

 

Oncorhynchus mykiss

n

Min.

Max.

Geometric mean/lowest value

OECD 203

 

/

/

/

/

 

1

1,170

1,170

1,170

 

2

340.5

1,000.0

340.5

Pimephales promelas

n

Min.

Max.

Geometric mean/lowest value

OECD 203

 

4

40.8

810.0

194.2

 

11

52.0

3,598.0

422.0

 

21

113.8

3,249.0

602.4

/: no data available

 

- Chronic reference values

An overview of the selected high quality species mean/lowest chronic toxicity data for the 3 different pH classes is provided in the Table below.

Table xxxx: Overview of the selected high quality long-term toxicity data for the individual species (L(E)C10/NOEC values expressed as µg/L) for the 3 pH classes (lowest values in bold)

Test organism

Standard method

NOEC/L(E)C10 (µg/L)

pH: 5.5-6.5

pH: >6.5-7.5

pH: >7.5-8.5

Higher plants

 

 

 

 

Lemna minor

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 221

 

1

186.0

186.0

186.0

Root growth rate

 

1

1,025.0

1,025.0

1,025.0

Root growth rate

 

3

85.0

348.0

85.0

Root growth rate

Algae

 

 

 

 

Pseudokirchnerella subcapitata

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 201

 

6

25.5

190.0

58.0

Growth rate

 

6

6.1

18.9

9.3

Growth rate

 

2

6.1

6.2

6.1

Growth rate

Chlorella kessleri

n

Min.

Max.

Geometric mean/lowest value

OECD 201[2]

 

1

120.0

120.0

120.0

 

/

/

/

/

 

/

/

/

/

Invertebrates

 

 

 

 

Daphnia magna

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 211

 

/

/

/

/

 

1

9.0

9.0

9.0

Mortality

 

3

78.0

406.6

78.0

Mortality

Ceriodaphnia dubia

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

ASTM n° E1295-01

 

2

33.3

69.5

33.3

Reproduction

 

21

1.7

354.9

25.3

Reproduction

 

16

20.4

107.4

52.2

Reproduction

Fish

 

 

 

 

Oncorhynchus mykiss

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 204; OECD 210; OECD 212

 

/

/

/

/

 

3

18.9

423.0

18.9

Abnormalities

 

1

121.0

121.0

121.0

Growth

Cyprinus carpio

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 204; OECD 210; OECD 212

 

1

17.8

17.8

17.8

Mortality

 

/

/

/

/

 

/

/

/

/

Lepomis macrochirus

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 204; OECD 210; OECD 212

 

/

/

/

/

 

1

70.0

70.0

70.0

Growth

 

/

/

/

/

Salvelinus fontanilis

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 210

 

/

/

/

/

/

 

1

39.4

39.4

39.4

Growth

 

/

/

/

/

/

Salvelinus namaycush

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 210

 

/

/

/

/

/

 

1

72.0

72.0

72.0

Mortality

 

/

/

/

/

/

Salmo salar

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 210

 

1

48.0

48.0

48.0

Mortality

 

/

/

/

/

 

/

/

/

/

Ictalurus punctatus

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 210

 

/

/

/

/

/

 

2

98.2

100.4

98.2

Growth

 

/

/

/

/

/

Pimephales promelas

n

Min.

Max.

Geometric mean/lowest value

Most sensitive endpoint

OECD 204; OECD 210; OECD 212

 

1

29.3

29.3

29.3

Mortality

 

7

20.0

1,420.4

94.1

Mortality

 

3

174.4

1,337.7

174.4

Mortality

/: no data available

A summary of the selected acute and chronic reference values at the different pH’s is provided inTable xxx.

Table xxx: Overview of the selected high quality acute and chronic toxicity data for the individual species (expressed as µg dissolved Pb/L) for the 3 pH classes

pH range

Reference values (µg dissolved Pb/L)

Acute reference value

Chronic reference value

pH 5.5-6.5

pH >6.5-7.5

pH >7.5-8.5

73.6

37.8

20.5

17.8

9.0

6.1

 

[1]Sensu stricto, the speciesChlorella vulgarisshould be used according to the OECD guideline. However, both species belong to the same genus and thereforeChlorella kessleriwas selected for classification purposes

[2]Sensu stricto, the speciesChlorella vulgarisshould be used according to the OECD guideline. However, both species belong to the same genus and thereforeChlorella kessleriwas selected for classification purposes

The derived reference toxicity data together with transformation dissolution testing and the Unit world model were used to determine the classifications for the various lead grades. Please find the conclusions for the various lead grades which are discussed in more detail in the C&L document in section 13 of the dossier.

Massive Lead classification

Appropriate and high quality Transformation Dissolution data are available for 2 forms of massive Lead metal corresponding with aged and non-aged material. The metal can for the environmental endpoint be clearly differently classified from the Lead powder form given that all CLP criteria to allow a distinctive classification are fulfilled:

1).both are produced in a separate way

2).both have different dissolution kinetics and equilibrium

3).both result in different environmental classification categories

Toxicity data are available for the 3 relevant classes for environmental hazard classification for metals (pH 5,5 to 6,5, 6,5 to 7,5 and 7,5 to 8,5) while Transformation Dissolution was measured at both pH6 (highest release rate) and at pH 7 (highest toxicity) and estimated at pH 8. While the toxicity increases with higher pH, the Transformation Dissolution reflects the opposite relationship. The ratio dissolution/toxicity is the highest for pH 6 justifying the use of pH 6 as the relevant pH for the environmental hazard assessment at acute and chronic level for the hazard identification of Lead in massive form. The solubility levels in the Transformation Dissolution for the aged and the non aged sample at pH 6, are comparable and low: - 7d TDp at pH 6 corresponds respectively with: o 567 or 428 μg/l at 100mg/l dosing and o 56,7 or 43,2 μg/l at 10 mg/l

°extrapolated value

The TICKET UWM model was successfully applied to demonstrate rapid degradation equivalent (rapid elimination from the water column) for the soluble Pb ion. Indeed 70 % elimination from the water column is already reached in 2 h’s while also the binding to sediments is assured (no net release) being it slower than the elimination rate in water. The REACH Registration file further concludes no bioaccumulation levels that could lead to a concern for classification.

All this evidence for Pb massive metals leads to the following conclusions:

- Under CLP, 1st ATP : No environmental classification for both forms (the non-aged and aged forms)

- Under GHS 3rd rev : Acute 3 hazard ID with no chronic hazard

- Under CLP, 2nd ATP : no environmental classification for both massive forms

- No acute nor chronic M factor is required for the use of Lead in massive form for mixtures and alloys      

In line with Annex 4 Chapter IV.5.3 of the Guidance on the Application of the CLP Criteria, metals must be classified by comparing Transformation Dissolution data with toxicity data for the soluble metal ion. The availability of toxicity information on the soluble ion (developed under the Lead metal registration file) makes the requirement for aquatic ecotoxicity tests on Lead metal redundant but also irrelevant since requiring nominal testing, which is not allowed for metals.

Lead powder classification

24h TDP screening information is available for Lead metal powder. Lead metal powder with an aerodynamic diameter of 75 μm fails the TDp already at 24h because of the high solubility (> 3000 μg/l) compared to the acute toxicity reference value of 73,6 μg/l at the equivalent pH level (pH6) Any further 7d or 28 d testing in accordance with the CLP guidance would therefore irrelevant. Lead metal powder should therefore be classified as the soluble Pb ion being :

- Under CLP : Acute 1 – Chronic 1,

- Under GHS 3rd rev : Acute 1 – Chronic 1,

The lowest acute toxicity reference value of 20,5 μg soluble Lead ion/l (at pH 8) leads to an acute M actor of 10 while the lowest chronic toxicity reference value of 6,1 μg soluble Lead ion/l (at pH 8) leads to a chronic M factor 1, assuming Lead being considered as a readily degradable substances

This environmental classification recommendation holds for mixtures composed of > 25 % of Lead powder

In line with Annex 4 Chapter IV.5.3 of the Guidance on the Application of CLP Criteria, metals must be classified by comparing Transformation Dissolution data with toxicity date for the soluble metal ion. The availability of toxicity information on the soluble ion (developed under the Lead metal registration file) makes the requirement for aquatic ecotoxicity tests on Lead metal redundant but also irrelevant since requiring nominal testing, which is not allowed for metals.

Further full acute 7d or full chronic 28 d TDp testing is not required and irrelevant given the dissolved concentration already classifies the substance after 24h.

Lead with arsenic classification

See above for the justifications for no classification of massive lead metal. The classification of the arsenic containing grade of massive lead metal has been derived by applying the CLP rules for classifying mixtures, using a read-across approach from available TDp data for massive lead metal (99%); the presence of arsenic is not expected to increase the release of soluble lead ions from the massive form.

The classification for lead with arsenic is aligned with the results of the Tier 1 MECLAS classificiation (February 2016).